New Combination Therapy Demonstrates 47% Reduction in Event-Free Survival Events
Why is this a game-changer for bladder cancer treatment? Merck, a global leader in healthcare, has announced groundbreaking results from the Phase 3 KEYNOTE-B15 trial, which demonstrated that the combination of KEYTRUDA (pembrolizumab) and Padcev (enfortumab vedotin-ejfv) significantly extends survival in patients with muscle-invasive bladder cancer (MIBC). This perioperative regimen, used both before and after surgery, marks a significant advancement in the treatment landscape for this aggressive form of cancer.
The trial, which included 808 patients, showed a 47% reduction in the risk of event-free survival (EFS) events and a 35% reduction in the risk of death compared to neoadjuvant chemotherapy and surgery. These results, presented at the 2026 American Society of Clinical Oncology (ASCO) Genitourinary (GU) Cancers Symposium, highlight the potential of this combination to become a new standard of care for cisplatin-eligible patients with MIBC.
Key Insights at a Glance
- Event-Free Survival: KEYTRUDA plus Padcev reduced the risk of EFS events by 47%.
- Overall Survival: The combination reduced the risk of death by 35%.
- Pathologic Complete Response: The pCR rate increased from 32.5% to 55.8%.
- Clinical Significance: These findings reinforce the potential of this combination to play a foundational role in bladder cancer care.
Why Muscle-Invasive Bladder Cancer Remains a Critical Challenge
Muscle-invasive bladder cancer (MIBC) is a particularly aggressive form of the disease, with a high risk of recurrence and metastasis. For nearly 25 years, the standard of care for cisplatin-eligible patients has been neoadjuvant cisplatin-based chemotherapy followed by surgery. However, this approach has limitations, with nearly half of patients experiencing recurrence. The need for more effective treatment options has been a pressing concern in the oncology community.
The KEYNOTE-B15 trial addresses this critical gap by demonstrating a statistically significant and clinically meaningful improvement in both event-free survival and overall survival. This breakthrough not only extends the lives of patients but also improves their quality of life by reducing the risk of disease progression and recurrence. The urgency of this issue is underscored by the high recurrence rates and the limited treatment options available to patients with MIBC.
The Regulatory Clock Is Already Running for Bladder Cancer Treatment
Just as a marathon runner must pace themselves to finish strong, Merck’s KEYTRUDA plus Padcev combination therapy is pacing the field in the race to improve outcomes for patients with MIBC. The trial’s success in demonstrating a 47% reduction in the risk of EFS events and a 35% reduction in the risk of death is a significant milestone. These results are not just numbers; they represent real, tangible improvements in patient outcomes and survival rates.
The trial’s findings are particularly noteworthy given the long median follow-up of 33.6 months. This extended follow-up period provides robust evidence of the therapy’s long-term benefits. The pathologic complete response (pCR) rate, which increased from 32.5% to 55.8%, further underscores the effectiveness of the combination. As regulatory authorities worldwide review these results, the potential for this combination to become a new standard of care is becoming increasingly clear.
Merck’s KEYTRUDA Plus Padcev Redefines Bladder Cancer Care
Merck is redefining the treatment landscape for muscle-invasive bladder cancer with its KEYTRUDA plus Padcev combination therapy. This perioperative regimen, which involves administering the drugs both before and after surgery, has shown remarkable efficacy in extending survival and reducing the risk of disease progression. The trial’s primary endpoint of event-free survival (EFS) was met with a 47% reduction in EFS events, and the secondary endpoints of overall survival (OS) and pathologic complete response (pCR) rate also demonstrated significant improvements.
Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories, emphasized the significance of these findings: “These results demonstrate the strength and consistency of KEYTRUDA plus Padcev in treating muscle-invasive bladder cancer. Showing a survival benefit in cisplatin-eligible patients in the perioperative setting reinforces the potential of this combination to play a foundational role in bladder cancer care.”
Future Outlook
The success of the KEYNOTE-B15 trial is just the beginning. Merck plans to share these results with regulatory authorities worldwide, paving the way for potential regulatory filings. The company is also conducting additional Phase 3 studies to evaluate KEYTRUDA across all stages of bladder cancer, including non-muscle-invasive, muscle-invasive, and metastatic disease. This comprehensive approach underscores Merck’s commitment to advancing the treatment landscape for patients with bladder cancer.
The future of bladder cancer treatment is evolving rapidly, and the KEYTRUDA plus Padcev combination is at the forefront of this progress. As more data becomes available and regulatory approvals are secured, the impact on patient outcomes is expected to be profound.
Conclusion
The KEYNOTE-B15 trial’s results represent a significant breakthrough in the treatment of muscle-invasive bladder cancer. By extending survival and reducing the risk of disease progression, the KEYTRUDA plus Padcev combination therapy has the potential to become a new standard of care. For healthcare providers and patients alike, this development offers hope and a more promising future. How is your practice preparing to integrate this new treatment option?
About Merck
At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities.
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